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510(k) K083002

SYSMEX UF-500I AUTOMATED URINE PARTICLE ANALYZER by Sysmex America, Inc. — Product Code LKM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 2009
Date Received
October 8, 2008
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Counter, Urine Particle
Device Class
Class II
Regulation Number
864.5200
Review Panel
HE
Submission Type

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